FDA Withdraws Approval of Oxycodone Hydrochloride and Ibuprofen Tablets ANDA

Summary

The FDA's Center for Drug Evaluation and Research (CDER) is withdrawing approval of an abbreviated new drug application (ANDA) for oxycodone hydrochloride and ibuprofen tablets due to repeated failure to submit required data supporting bioequivalence. The ANDA holder waived its right to a hearing.